MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT HIGH-SENSITIVITY TROPONIN I (TNIH); IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report a falsely elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on an advia centaur xpt system.The erroneous result was reported to the physician(s), who did not question the result.The sample was repeated on an initial advia centaur xpt system and an alternate advia centaur xpt system.The repeat results were lower than the erroneous result.A corrected report was issued.The customer stated no recent calibration or quality control (qc) issues prior to running the affected patient sample and after running the affected patient sample.Siemens investigation included an assessment of reagent, instrument, and sample data.Reagent issues were ruled out based on review of the qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.Assessment of instrument performance included a review of qc, repeated samples with good reproducibility.The patient samples are only spun for 7 minutes.Based on the available information, the cause of the discordant result is consistent with a potential sample integrity issue.Return of the patient sample for further investigation is not warranted because discordant result was not reproducible.No further evaluation of the device is required.
Event or Problem Description
A falsely elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on an advia centaur xpt system.The erroneous result was reported to the physician(s), who did not question the result.The sample was repeated on the initial advia centaur xpt system and an alternate advia centaur xpt system.The repeat results were lower than the erroneous result.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih result.

• Brand Name: ADVIA CENTAUR XPT HIGH-SENSITIVITY TROPONIN I (TNIH)
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney st.; east walpole, MA 02032 ; 7372808688
• MDR Report Key: 17831207
• Report Number: 1219913-2023-00242
• Device Sequence Number: 14272410
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: 00630414602929
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2024
• Device Model Number: N/A
• Device Catalogue Number: 10994775
• Device Lot Number: 093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 09/28/2023
• Date Device Manufactured: 05/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female